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Registration Dossier
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EC number: 940-786-0 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- June 15, 1992 - June 22, 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test procedure according to national standards.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Directives 83/467 and 84/449
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Benzene, mono-C10-14-alkyl derivs.
- EC Number:
- 270-486-9
- EC Name:
- Benzene, mono-C10-14-alkyl derivs.
- Cas Number:
- 68442-69-3
- IUPAC Name:
- dodecylbenzene
- Reference substance name:
- Dodecylbenzene
- EC Number:
- 204-591-8
- EC Name:
- Dodecylbenzene
- Cas Number:
- 123-01-3
- IUPAC Name:
- dodecylbenzene
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Conelli - Arona
- Weight at study initiation: 2.5-3.5 kg
- Housing: stainless steel cages
- Diet (e.g. ad libitum): pellet complete diet
- Water (e.g. ad libitum): filtered tap water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2 degree C
- Humidity (%): 55 +/- 15%
- Air changes (per hr): 25 changes/hr
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark
IN-LIFE DATES: From: June 15, 1992 To: June 22, 1992
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated areas of same animal were used as controls
- Amount / concentration applied:
- TEST MATERIAL
- Concentration (if solution): 100% - Duration of treatment / exposure:
- 4 hrs
- Observation period:
- 0, 24, 48, and 72 hrs, and 5 and 7 days after removal of the patches
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: dorsal area of the trunk
- Type of wrap if used: 2.5 x 2.5 cm gauze pads secured by thin bands of adhesive wrap, then covered with rubberized cloth
SCORING SYSTEM: Draize
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 hrs
- Score:
- 0.62
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days
- Irritant / corrosive response data:
- Erythema (maximum score of 2) was seen in all animals at the 24 hr observation. In 3 of the animals, the erythema persisted throughout the experiment, and was not fully resolved by the end of the experiment on day 7. Edema was seen in one animal at the 24 hr observation only.
Any other information on results incl. tables
Results of Skin Irritation Study
Time after patch removal |
Animal |
||||||
Erythema |
1 |
2 |
3 |
4 |
5 |
6 |
Mean |
1 hr |
0 |
0 |
0 |
0 |
0 |
0 |
0.00 |
24 hrs |
2 |
1 |
2 |
1 |
1 |
1 |
1.33 |
48 hrs |
2 |
1 |
1 |
1 |
1 |
1 |
1.17 |
72 hrs |
1 |
1 |
1 |
1 |
1 |
1 |
1.00 |
5 days |
1 |
1 |
1 |
1 |
1 |
1 |
1.00 |
7 days |
0 |
0 |
1 |
0 |
1 |
1 |
0.50 |
Oedema |
|||||||
1 hr |
0 |
0 |
0 |
0 |
0 |
0 |
0.00 |
24 hrs |
1 |
0 |
0 |
0 |
0 |
0 |
0.17 |
48 hrs |
0 |
0 |
0 |
0 |
0 |
0 |
0.00 |
72 hrs |
0 |
0 |
0 |
0 |
0 |
0 |
0.00 |
5 days |
0 |
0 |
0 |
0 |
0 |
0 |
0.00 |
7 days |
0 |
0 |
0 |
0 |
0 |
0 |
0.00 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 (mild irritant)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance caused only mild irritation, however, symptoms were not fully resolved by the end of the experiment.
- Executive summary:
In cases where no data were available on the target substance, Benzene, C15 -16 -alkyl derivs., data were read across from a structurally related material (the test substance).
This study examined the potential of the test substance to cause skin irritation. 6 rabbits were exposed to undiluted test substance on shave skin for 4 hrs. After the exposure the animals were scored for skin irritation, and were scored again at 24, 48, and 72 after end of exposure. Since symptoms were not fully resolved, further observations were made at 5 and 7 days after end of exposure. At the 24 hr observation, all animals showed signs of erythema (maximum score of 2), and one animal showed signs of edema (score of 1). There were no signs of edema in any animal at the 48 hr observation. Erythema persisted in all animals through day 5, and in 3 of the animals, erythema was not fully resolved at the end of the experiment on day 7. Though all symptoms of irritation were mild, the irritation was not fully reversible within the study period.
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